1411. The Use of Fidaxomicin for the Treatment of Clostridium Difficile Infection (CDI) in Patients with Cancer
Session: Poster Abstract Session: Clostridium difficile
Saturday, October 5, 2013
Room: The Moscone Center: Poster Hall C
Background: CDI is a major concern in patients with cancer and can be associated with significant morbidity and mortality. Recurrent CDI represents a major treatment challenge for which new therapeutic options are needed. Fidaxomicin (FDX), an oral macrocyclic antibiotic, demonstrated superior clinical outcomes in 2 recent clinical trials when compared to oral vancomycin. We report our experience with the use of this new agent in cancer patients with CDI.

Methods: A search of the pharmacy database identified 22 episodes of CDI treated with FDX between 5/1/11 to 1/31/13. Data on demographics, reason for initiation of FDX, and outcomes including recurrences were collected.

Results: Majority of patients were male (55%) with a mean age of 58 years (range: 20-83 years). Most common underlying malignancies were lymphoma in 9(41%), leukemia in 7(32%), and solid tumors in 6(27%); 9(41%) patients had a prior stem cell transplant.  A total of 2(9%) of patients were neutropenic and 4(22%) were receiving active chemotherapy. Colitis was seen on CT imaging in 10(45%) cases, and serum creatinine was elevated 50% above baseline in 8(36%) patients. FDX was used for recurrent CDI in 16 (72%) patients and for failure of both metronidazole and oral vancomycin in 6 (28%) for a mean duration of 13 days (range: 10-28 days). Most patients were on concomitant antimicrobials during CDI treatment; 19(86%). Clinical cure of FDX was 91% with only 2 patients with documented failures; one patient with severe colitis from both graft vs. host disease and CDI expired and 1 patient recovered after successfully treated with oral vancomycin. Recurrent CDI within 30 days of FDX therapy was seen in only 3 (15%) patients who had multiple prior recurrences. FDX was well tolerated and there were no discontinuations due to drug-related adverse events.

Conclusion: FDX was highly effective in cancer patients treated for first episode of CDI after failure of standard therapy and in patients with recurrent CDI. This was remarkable given the high number of high-risk patients who continued to receive concomitant antimicrobial therapy, which is common in this immunocompromised patient population.

Amin Esmaily-Fard, PharmD, University of Texas MD Anderson Cancer Center, houston, TX, Frank Tverdek, PharmD, Clinical Pharmacy Programs, The University of Texas MD Anderson Cancer Center, Houston, TX, David Crowther, University of Texas MD Anderson Cancer Center, Houston, TX, Shashank S. Ghantoji, MD, MPH, Center for Infectious Diseases, University of Texas School of Public Health, Houston, TX, Javier A. Adachi, MD, FIDSA, Dept. of Infectious Diseases, Infection Control and Employee Health, The University of Texas M. D. Anderson Cancer Center, Houston, TX and Roy Chemaly, MD, MPH, Infectious Diseases, Infection Control and Employee Health, The University of Texas MD Anderson Cancer Center, Houston, TX

Disclosures:

A. Esmaily-Fard, None

F. Tverdek, None

D. Crowther, None

S. S. Ghantoji, None

J. A. Adachi, Optimer Phamaceuticals, Inc: Grant Investigator, Research grant

R. Chemaly, None

Findings in the abstracts are embargoed until 12:01 a.m. PST, Oct. 2nd with the exception of research findings presented at the IDWeek press conferences.